Midostaurin (PKC412) for Locally Advanced Rectal Cancer

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study combines midostaurin (PKC412) with radiation and a standard chemotherapy drug call 5-Fluorouracil (5-FU) for subjects with advanced rectal cancer. Midostaurin is a type of kinase inhibitor which works by blocking proteins associated with cancer cell growth. Previous studies also suggest that midostaurin may help increase the effectiveness of radiation therapy. In this research we are looking for the highest dose of midostaurin that can be given safely in combination with standard chemoradiation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: 4'-N-benzoylstaurosporine; Midostaurin; Staurosporine

Criteria

Inclusion Criteria:

• Adenocarcinoma of the rectum

• T3/4 or N+ disease

• Life expectancy > 3 months

• Normal organ and marrow function

Exclusion Criteria:

• Metastatic disease

• Pregnant or breastfeeding

• Prior radiotherapy

• Receiving other investigational agents

• History of inflammatory bowel disease

• Active scleroderma or CREST syndrome

• Uncontrolled intercurrent illness

• History of a different malignancy unless disease free for at least 5 years

• HIV or active viral hepatitis

• Impaired cardiac function